
The Leonardtown, MD Rotary Club is building 3 dimensional reefs out of concrete blocks and 1 foot balls (with wholes) to increase the oyster population in the Chesapeake Bay. The new reefs are located in a pro-tected part of the St Mary’s Ri-ver. M & F oysters produce millions of “spat” offspring in a lab. In three months the spat is the size of a quarter and are transferred on an oyster shell to the artificial reef. The higher they get on the reef the more algae (and more water current) the bigger they get. The oysters float out into the Bay. Each oyster filters 55 lb of water a day and releases nitro-gen thereby cleaning up the Bay. The St. Mary’s County OYSTER FESTIVAL is on Oct 19 & 20. For more info call 301-863-5015 or go to www.usoysterfest.com
Last week Fellow member, Dr Bruce, talked again on toxic elements. This time he talked about how toxic elements (arsenic, lead, mercury, and cadmium) get into dietary supplements from foreign countries ( China, India, and others) and how hard it is for the US Government to regulate and detect the introduction of these toxic elements. The problem is that foreign countries use waste water sewage sludge as fertilizer and the dietary supplement ingredients may come from a third country. The Dietary Supplement Health and Education Act of 1994 (DSHEA) directed FDA to promote good manufacturing practices, truthful labels, and (after) adverse event reporting. An active Q&A followed Bruce’s talk.
Dr Lostritto Talked about the Center for Drug Evaluation and Research within the FDA. The CDER evaluates new drugs and generics ( to make sure they are equivalent. ). The CDER mission is to protect public health, approve drugs, give oversight and regula-tions,safety, drug industry gui-dance,and provide global in-spection teams. CDER drug approvals go through 3 pha-ses: (1) Pre-clinical Research; (2) Clinical studies on humans; and (3) New Drug Application (NDA). The review includes the drug, enclosure, labeling, and contract.